PETNET Solutions and Blue Earth Diagnostics expand Axumin availability to meet increasing clinical demands.
Axumin® (fluciclovine F 18) injection, a PET radiopharmaceutical used for the detection and localization of biochemically recurrent prostate cancer, has experienced strong success since receiving FDA approval in May 2016. Based on increasing awareness and demand for the fluciclovine F 18 tracer, PETNET Solutions—the exclusive commercial supplier of Axumin in the United States—in collaboration with Blue Earth Diagnostics, plans to expand Axumin production and distribution from 17 to 31 radiopharmacies by the end of 2018. As a result of this expansion, PETNET Solutions estimates Axumin will be available to more than 80% of eligible patients in the US.
Partnering to meet an unmet need
Prostate cancer is the second leading cause of cancer death in men in the US, and about 1 in 9 men will be diagnosed with the disease in their lifetime.1 In 2018 alone, the American Cancer Society estimates there are roughly 164,690 new cases of prostate cancer.1 Unfortunately, 20-40% of treated patients will experience disease recurrence,2 which equates to about 60,000 patients per year. These recurrences, indicated by rising prostate-specific antigen (PSA) levels, may be difficult to detect using traditional MR and CT imaging. By using Axumin with PET/CT imaging, clinicians have a new way to detect and localize sites of recurrence, which may facilitate new insights for appropriate patient management.
“Axumin is a remarkable story if you look at what has happened,” says Jonathan Allis, Chief Executive Officer (CEO) at Blue Earth Diagnostics, a private diagnostics company focused on the development and commercialization of innovative PET imaging agents. “If you look at the number of patients who are living with recurrent prostate cancer, the demand for Axumin has grown very rapidly and, in terms of availability, we’re continuing to ramp up US production and distribution to meet the growing demand, and we’re working closely with our colleagues at PETNET Solutions to achieve this.”
As early as 2014, Blue Earth Diagnostics was searching for an appropriate commercial-distribution partner for Axumin in the United States. With a patient-driven mission and dedication to the development and commercialization of innovative molecular imaging products, Blue Earth Diagnostics found a solid partner with a similar patient-driven focus at PETNET Solutions.
“PETNET Solutions is just a fantastic partner for us in the United States,” Allis continues. “Obviously, PETNET has the best radiopharmaceutical distribution footprint, but I think beyond that, we found PETNET Solutions to be people who are passionate about PET and who think about positron emission tomography first, and economics second. And that made us feel like we were making a good choice for a partner in this important endeavor.”
“Now we have the chance to actively introduce a new specialty to the value of PET/CT.”
The success of Axumin is also catching the attention of other Intellectual Property (IP) holders, who are beginning to see the value and potential of investing in other innovative imaging agents.
“For PETNET,” Scott emphasizes, “our vision is to be the provider and contract manufacturer of choice in PET/CT because we believe in expanding the availability of novel PET imaging agents. We want to ensure new imaging agents like Axumin are available to our customers, which helps them grow and expand their business. That foundational belief is a vital part of our own business, especially as more people start to invest in research and development in this area.”
Clinical validation
Data on the clinical utility of fluciclovine F 18 PET/CT were recently presented at the American Urological Association (AUA) conference in May 2018. The investigational LOCATE study evaluated the clinical utility of fluciclovine F 18 PET/CT imaging in men with recurrent prostate cancer following prior treatment. It recorded a patient‘s intended treatment plan prior to fluciclovine F 18 PET/CT and then recorded how it was altered after the scan was reviewed. Results indicated that 59% (126/213) of patients had their clinical management changed when results of the fluciclovine F 18 PET/CT imaging were added to the diagnostic work-up. Of those changes, 78% (98/126) were classified as “major” (ie, a change in treatment modality).3
Allis notes, “we believe the fact that nearly 60% of patients had their management changed after they had a fluciclovine F 18 PET/CT scan really shows why we’re seeing increased interest about fluciclovine F 18 PET/CT among the clinical community. Additionally, fluciclovine F 18 is now included in oncology guidelines and is approved for Medicare reimbursement.”
“At the end of the day,” Scott concludes, “PETNET is prepared to increase capacity and expand production and distribution of Axumin in the United States to meet any demand that we see, given the indication for recurrent prostate cancer.”
Loma Linda University and PETNET Solutions partner to progress molecular imaging
The Center for Imaging Research at Loma Linda University (LLU) School of Medicine, in California, USA, manages their own radiochemistry lab and also houses one of Siemens Healthineers’ PETNET Solutions radiopharmaceutical and commercial production facilities. Operating under its own license and leasing the space from the university, PETNET Solutions reliably supplies a range of short-lived biomarkers to researchers and clinicians at LLU, as well as their collaborators, while fulfilling commercial distribution needs throughout Southern California.
To observe how this unique partnership creates opportunities for students to engage in the field of molecular imaging, watch The Future of Nuclear Medicine at either of the links below.
U.S. Indication and Important Safety Information for Axumin*
Indication
Axumin® (fluciclovine F 18) injection is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.
NOTE: Axumin (fluciclovine F 18) injection is not currently approved in the United States for treatment planning in men with biochemically recurrent prostate cancer.
Important Safety Information
- Image interpretation errors can occur with Axumin PET imaging. A negative image does not rule out recurrent prostate cancer and a positive image does not confirm its presence. The performance of Axumin seems to be affected by PSA levels. Axumin uptake may occur with other cancers and benign prostatic hypertrophy in primary prostate cancer. Clinical correlation, which may include hitopathological evaluation, is recommended.
- Hypersensitivity reactions, including anaphylaxis, may occur in patients who receive Axumin. Emergency resuscitation equipment and personnel should be immediately available.
- Axumin use contributed to a patient’s overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Safe handling practices should be used to minimize radiation exposure to the patient and health care providers.
- Adverse reactions were reported in ≤ 1% of subjects during clinical studies with Axumin. The most common adverse reactions were injection site pain, injection site erythema and dysgeusia.
To report suspected adverse reactions to Axumin, call 1-855-AXUMIN1 (1-855-298-6461) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Full U.S. Axumin prescribing information is available here.